Impact of Brexit on the Pharma & Medical Device Industries

Hear the latest information from our expert speaker panel to help you understand the changes that are required and ensure you are up to date with Brexit!

18 Mar 2019

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 15 Feb

Book now

Course overview

With Britain’s exit from the European Union fast approaching, the new arrangements for all aspects of the regulation of pharmaceuticals, medical devices and IVDs between the UK and EU 27 pose major challenges.

The ramifications of Brexit after more than 40 years of ever-deepening integration and alignment across the life science sector will be immense, whatever final form Brexit takes.

This course will enable you to hear the latest information from our expert panel of speakers to help you understand the changes that are required and ensure you are ready as the deadlines approach.

Benefits of attending:

  • Hear the latest information on Brexit and how it will affect the life science sector
  • Discuss the outstanding issues and what actions need to be taken to prepare for Brexit
  • Gain an insight into the MHRA perspective on Brexit
  • Consider the specific issues relevant to both the medical technology and pharma industries
  • Explore the impact on both existing and new products

Who should attend?

This course will be of interest to anyone within the pharmaceutical or medical technology sectors seeking an update on the impact of Brexit.

Programme

Brexit – the MHRA perspective

  • Where are we now?
  • What are the outstanding Issues?
  • What will happen next?

Question and answer session

The medical technology sector – what are the issues and how to operate from 30/3/19

  • How Brexit will impact on the implementation of the Medical Device Regulation and the IVD Regulation
  • Impact for existing and new products
  • Impact on the redesignation of Notified Bodies and of products under the new legislation
  • Position of UK-based Authorised Representatives Philip Brown, ABHI

Panel discussion

The pharma sector – what actions need to be taken to prepare for Brexit

  • The alignment for the approval of new products and changes and variations to existing products
  • The supply chain concerns, product release and batch testing
  • Transfer of market authorisations for UK authorised products
  • Issues where the UK is rapporteur/co-rapporteur – Reference Member State (RMS )
  • Position for orphan drugs, paediatrics requirements, exclusivity and intellectual property
  • Pharmacovigilance issues including location of the QPPV
  • Future clinical trial controls David Jefferys, Eisai

How to operate in the UK post Brexit

  • What will the key issues be?

Final discussion session

Book now

18 Mar 2019
18 Mar 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 15 Feb
Enrol now

Previous customers include...

  • B.Braun Medical
  • Bionical-Emas
  • Boots Uk Ltd
  • DePuy International Ltd, T/A DePuy CMW
  • Elekta
  • Gilead Sciences International Ltd
  • Interdos B.V.
  • Intertek Melbourn
  • Molnlycke Health Care
  • Pen & Tec Consulting Group, S.L.
  • STD Pharmaceutical Products Ltd

Very competent, 'plugged in' speakers with excellent up to date strategic knowledge. Not widely available.

Lisa White, CMO, Bionical-Emas

All speakers were very knowledgeable. Content and speakers were perfect. A great course.

Adam Burton, Business Development Manager, Intertek Melbourn

The organisation and the speakers very knowledgable.

Hector Velasquez-Estay, Managing Director, Pen & Tec Consulting Group, S.L.

All speakers were clear and answered questions well, however there is so much uncertainty re; brexit it was difficult to provide clear guidance. Very informative and helpful for such an important topic.

Mary Crook, Associate Director, Gilead

Speakers were really engaging and the session was quite interactive

Farah Valli, Senior Regulatory Associate, DePuy International Ltd, T/A DePuy CMW